Clinical trialPhase 3Ovarian cancer

Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

N Engl J Med · 2021407 patients

Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, et al. N Engl J Med. 2021. 385:2123-2131

Study type: Clinical trial
Study name: DESKTOP III (AGO-OVAR OP.4)
Phase: Phase 3
Design: International multicentre randomised trial
Sample size: 407 patients
Source: N Engl J Med · 2021
Trial registration: NCT01166737

In plain words

If ovarian cancer comes back more than 6 months after the last platinum chemotherapy and the patient is in good condition (good general health, little fluid in the abdomen, and all the tumour removed at the first operation), a second operation to remove all the tumour followed by chemotherapy adds about 8 months to life on average, especially if the surgeon can remove all of the tumour.

Key results

53.7 vs 46.0 months

Median overall survival

HR 0.75 (95% CI 0.59–0.96); P=0.02

75.5%

Complete resection in the surgery group

Of patients who had surgery

61.9 months

Median overall survival with complete resection

Drugs in this study:Bevacizumab (Avastin)Carboplatin (Paraplatin)Gemcitabine (Gemzar)Paclitaxel (Taxol)

Dose and schedule cards

Platinum doublet + bevacizumab (GOG-0213, OCEANS)

Platinum-sensitive recurrence (more than 6 months after the last platinum)Cycle length: Every 21 daysOn the page “Ovarian cancer” · Platinum-sensitive recurrence

Platinum-sensitive recurrence (more than 6 months after the last platinum)

Drug	Dose	Route	Schedule
Regimen A: 6 to 8 cycles
Carboplatin + paclitaxel	AUC 5 + 175 mg/m² (3-hour infusion)	IV	Day 1
Regimen B: 6 to 10 cycles
Carboplatin + gemcitabine	AUC 4 (day 1) + 1,000 mg/m² (days 1 and 8)	IV	Days 1 and 8
With either regimen, then maintenance
Bevacizumab	15 mg/kg	IV	Day 1

Cycle length: Every 21 days
Duration: Chemotherapy for 6 to 8 (A) or 6 to 10 (B) cycles, then bevacizumab alone until progression

Pan-Asian ESMO guideline: platinum doublet (with PLD, gemcitabine or paclitaxel) plus bevacizumab [I, A], or a platinum doublet followed by PARP inhibitor maintenance if there is a response and no prior PARP inhibitor use [I, A]; bevacizumab should be continued until progression [I, A]. Assess for secondary cytoreductive surgery at an experienced centre before chemotherapy.

On the page “Ovarian cancer” · Platinum-sensitive recurrence

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Secondary cytoreductive surgery + platinum chemotherapy (206 patients)

Secondary cytoreductive surgery with maximal effort for complete resection (at centres selected for surgical experience), followed by platinum-based combination chemotherapy. The chemotherapy regimen was the investigator's choice, and no specific dose is given in the abstract or the ClinicalTrials.gov record. Complete resection was achieved in 75.5% of patients who had surgery (206 patients).

2Platinum chemotherapy alone (201 patients)

Investigator's choice of platinum-based combination chemotherapy, without surgery; no specific dose is given in the available sources (201 patients).

Source of the regimen details: Abstract of the paper and ClinicalTrials.gov NCT01166737 (investigator's choice of platinum chemotherapy; doses not stated in these sources; the full text was not available to us)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients with a first relapse of platinum-sensitive invasive epithelial ovarian, fallopian tube or primary peritoneal cancer (progression-free interval of at least 6 months after the end of the last platinum-containing treatment), with a positive AGO score: ECOG performance status 0, ascites less than 500 mL and complete resection at primary surgery (if unknown, initial FIGO stage I/II). Complete resection by midline laparotomy had to appear feasible. Exclusion criteria (ClinicalTrials.gov): more than one prior chemotherapy, second or later relapse, platinum-resistant disease, unresectable metastases and drugs increasing surgical risk (such as oral anticoagulants or bevacizumab).

Endpoints

Primary endpoint: overall survival. Secondary: quality of life and prognostic factors for survival.

Safety and side effects

No perioperative deaths (within 30 days) were observed, and quality of life up to one year of follow-up did not differ between the groups. Other surgical complication data are not reported in the abstract.

Clinical significance and place in guidelines

DESKTOP III established secondary cytoreductive surgery for selected patients with platinum-sensitive relapse. ESMO guideline (Pan-Asian adapted version 2025): patients with a first relapse more than 6 months after the last platinum should be assessed at a gynaecological oncology centre experienced in ovarian cancer surgery to identify candidates for cytoreductive surgery [I, A]. Patient selection (such as the AGO score) and centre experience are decisive.

Limitations

Open-label design; only patients with a positive AGO score were enrolled; the study was designed before PARP inhibitor maintenance became widespread; the benefit cannot be extrapolated to patients in whom complete resection is not achieved.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.